Safety and Efficacy Study of the Patient's Own Cultured Fat-Derived Stem Cells for Fistulas due to Crohn's disease.
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Where? Participants receive care at the Asan Medical Center, Seoul, Republic of Korea.
Why? To evaluate the safety and effectiveness of the use of the patient's own cultured fat-derived stem cells to treat Crohn's disease.
How? Patients will experience a mini-liposuction of abdominal fat. Stem cells will be derived from that fat and administered to the patient.
When? This study is currently accepting patients. Results will be monitored during and/or at the end of a period of 8 weeks following the treatment. Several digital pictures will be taken over that period of time.
Who may participate? Patients must meet the following criteria:
- Older than 18 years
- Prior diagnosis of Crohn's disease
- Patients who have Crohn's fistula
- Negative for urine beta-HCG for woman of childbearing age
- Agreement to participate, with signed informed consent
Who may not participate? Patients may not participate if they meet the following criteria:
- Patients who have allergy to cow-derived materials, or an anesthetic
- Patients with a diagnosis of auto immune disease other than Crohn's disease
- Diagnosis of HBV, HCV, HIV and other infectious disease
- Patients who have a symptom of septicemia
- Patients with active Tuberculosis
- Patient who are pregnant or breast-feeding
- Patients who are unwilling to use an "effective" method of contraception during the study
- Patients with a diagnosis of Inflammatory Bowel Disease other than Crohn's disease
- Patients who are sensitive to Fibrin glue
- Patients who have a clinically relevant history of abuse of alcohol or drugs, or habitual smoking
- Insufficient adipose tissue for isolation of stem cells
- Patients who are considered not suitable for the study by investigator
- Patients with a diagnosis of active refractory Crohn's disease
- Patients who have history of surgery for malignant cancer in the past 5 years
- Patients who have external opening(s) greater than 2 cm diameter
For more information:
Contact: Chang-sik Yu, M.D
Asan Medical Center
Seoul, Republic of Korea, 138-736